ACTIFUSE Indications

ACTIFUSE is a bone void filler intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is also intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects, including periodontal, oral, and craniomaxillofacial applications.

ACTIFUSE is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis and spine including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Important Risk Information for ACTIFUSE

ACTIFUSE is contraindicated where the device is intended as structural/load-bearing support in the skeletal system.

ACTIFUSE has not been cleared for use in vertebroplasty.

Other conditions representing contraindications include: severe vascular or neurological disease; uncontrolled diabetes; severe degenerative disease; uncooperative patients who cannot or will not follow post-operative instruction, including individuals who abuse drugs and/or alcohol; hypercalcemia, abnormal calcium metabolism; existing acute or chronic infections, especially at the site of the operation; inflammatory bone disease such as osteomyelitis; malignant tumors; severely impaired renal function.

Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.

The graft must be secured to prevent potential migration and should only be used in surgical procedures where bone grafts are adequately contained. Do not overfill or attempt to pressurize the bony defect site, as this may lead to extrusion of the product beyond the site of its intended application and damage the surrounding tissues, or may lead to fat embolization or embolization of the device into the bloodstream. The effect of mixing ACTIFUSE with substances other than sterile saline/water, autologous blood, or bone marrow aspirate is unknown.